Tel: +603 3102 3168 (OPERATION) +603 3161 2427 (LAB) +603 3102 3868 (QA) +603 6091 2055 (OFFICE)
Sina Sterilgamma Sdn Bhd is an independent certified sterilization provider. We provide ethylene oxide (ETO) sterilization service to medical devices manufactures in Malaysia and abroad. The ETO sterilization facility is currently located at Pelabuhan Klang,Malaysia, which provides easy access to port facilities for exporting products overseas. Preparation for shipping can be done direct from sterilization…
Sina Sterilgamma is currently accredited as follows 1) EN ISO 13485:2016 2) ISO 11135:2014 3) ISO 9001:2008 4) J-QMS 5) US FDA Registered
Sina Sterilgamma provides a sterilization consultancy to customers and training on ETO Sterilization and ISO documentations in our own facility in Port Klang or where ever require by customers.
Sina Sterilgamma operation team works 365 days a year, 24 hours per day. We have two shift to cater amount of requirement by customers and to ensure the sterilization procedure in smooth running.
We do provide a very good and knowledgeable team to handle Custom clearance and logistic matters to clients.
Congratulation to Sina-Sterilgamma team as renewal audit was successfully done on 10th and 11th of April 2018. We are certified and accredited as below: ISO 13485:2016 – Medical Devices Quality Management System Requirements ISO 11135:2014 – Sterilization of health care products — Ethylene oxide JQMS US FDA REGISTERED
